Immunogenicity and Reactogenicity of Pneumococcal Polysaccharide and Conjugate Vaccines in Native Elders

NCT00153543 | Completed Phase 1 Results

• 1 other identifier: CDC-NCID-3316
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that immune responses to 23-valent pneumococcal polysaccharide vaccine (PPV-23) could be improved in Alaska Native elders by immune priming with 7-valent pneumococcal conjugate vaccine (PCV-7), we assessed post-vaccination immune responses among Natives aged 55 years and older who were randomized into three arms: (1) one dose of PPV-23 according to current state and ACIP recommendations; (2) one dose of PCV-7 followed two months later with a dose of PPV-23; and (3) one dose of PCV-7 followed six months later with a dose of PPV-23.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

• Immune Responses

  antibody titers to 5 pneumococcal serotypes

  2 months after final dose of vaccine

Secondary Outcomes (1)

• Number of Participants With Systemic and Injection Site Reactions

  every day for 3 days after each injection

Study Arms (3)

PPV23

ACTIVE COMPARATOR

Receive one dose of PPV23

Biological: PCV7 + PPV23, 2 months; Biological: PCV7 + PPV23, 6 months

PCV7 + PPV23, 2 months

EXPERIMENTAL

Receive one dose of PCV7 + 1 dose of PPV23 2 months later

Biological: PCV7 + PPV23, 6 months

PCV7 + PPV23, 6 months

EXPERIMENTAL

Receive one dose of PCV7 + 1 dose of PPV23 6 months later

Biological: PCV7 + PPV23, 2 months

Interventions

PCV7 + PPV23, 2 months BIOLOGICAL

PCV7 + PPV23, 6 months; PPV23

PCV7 + PPV23, 6 months BIOLOGICAL

PCV7 + PPV23, 2 months; PPV23

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 to 70 years
• Alaska Native

You may not qualify if:

• Immune compromising condition
• Neurological disease
• Immune suppressive medication or immunoglobulin within 6 months
• Previous pneumococcal vaccination

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Alaska Native Tribal Health Consortium: collaborator
• Southcentral Foundation: collaborator

Study Sites (1)

Alaska Native Medical Center

Anchorage, Alaska, 99508, United States

Location

Related Publications (1)

• Miernyk KM, Butler JC, Bulkow LR, Singleton RJ, Hennessy TW, Dentinger CM, Peters HV, Knutsen B, Hickel J, Parkinson AJ. Immunogenicity and reactogenicity of pneumococcal polysaccharide and conjugate vaccines in alaska native adults 55-70 years of age. Clin Infect Dis. 2009 Jul 15;49(2):241-8. doi: 10.1086/599824.

  PMID: 19522655 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

There were a small number of subjects in each study group.

Results Point of Contact

• Title: Karen Miernyk
• Organization: CDC/Arctic Investigations Program

kmiernyk@cdc.gov

9077293453

Study Officials

• Karen Miernyk, MS

  Alaska Native Tribal Health Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Manager

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2002
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)